Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206557
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | AB | No | No |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | AB | No | No |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | AB | No | No |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/13/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/27/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
10/27/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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10/27/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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05/14/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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07/30/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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07/30/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
SIMVASTATIN
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
ZOCOR | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
ZOCOR | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
ZOCOR | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |